Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains
Issued Date
2024-03-07
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85187236982
Pubmed ID
38355318
Journal Title
Vaccine
Volume
42
Issue
7
Start Page
1506
End Page
1511
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine Vol.42 No.7 (2024) , 1506-1511
Suggested Citation
Bharucha T., Gangadharan B., Clarke R., Fernandez L.G., Arman B.Y., Walsby-Tickle J., Deats M., Mosca S., Lin Q., Stokes R., Dunachie S., Merchant H.A., Dubot-Pérès A., Caillet C., McCullagh J., Matousek P., Zitzmann N., Newton P.N. Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains. Vaccine Vol.42 No.7 (2024) , 1506-1511. 1511. doi:10.1016/j.vaccine.2024.01.019 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/97658
Title
Repurposing rapid diagnostic tests to detect falsified vaccines in supply chains
Author's Affiliation
Central Laser Facility
Mahidol Oxford Tropical Medicine Research Unit
Oxford University Hospitals NHS Foundation Trust
Émergence des Pathologies Virales
University of Huddersfield
University of Oxford
University of East London
Mahosot Hospital, Lao
Nuffield Department of Medicine
University of Oxford Medical Sciences Division
Agilent Technologies LDA UK Ltd
Mahidol Oxford Tropical Medicine Research Unit
Oxford University Hospitals NHS Foundation Trust
Émergence des Pathologies Virales
University of Huddersfield
University of Oxford
University of East London
Mahosot Hospital, Lao
Nuffield Department of Medicine
University of Oxford Medical Sciences Division
Agilent Technologies LDA UK Ltd
Corresponding Author(s)
Other Contributor(s)
Abstract
Substandard (including degraded) and falsified (SF) vaccines are a relatively neglected issue with serious global implications for public health. This has been highlighted during the rapid and widespread rollout of COVID-19 vaccines. There has been increasing interest in devices to screen for SF non-vaccine medicines including tablets and capsules to empower inspectors and standardise surveillance. However, there has been very limited published research focussed on repurposing or developing new devices for screening for SF vaccines. To our knowledge, rapid diagnostic tests (RDTs) have not been used for this purpose but have important potential for detecting falsified vaccines. We performed a proof-in-principle study to investigate their diagnostic accuracy using a diverse range of RDT-vaccine/falsified vaccine surrogate pairs. In an initial assessment, we demonstrated the utility of four RDTs in detecting seven vaccines. Subsequently, the four RDTs were evaluated by three blinded assessors with seven vaccines and four falsified vaccines surrogates. The results provide preliminary data that RDTs could be used by multiple international organisations, national medicines regulators and vaccine manufacturers/distributors to screen for falsified vaccines in supply chains, aligned with the WHO global ‘Prevent, Detect and Respond’ strategy.